TALENT PIPELINE - Clean Room Analyst - Microbiological Environmental Monitoring

Cambrex; Marlborough (MA); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading pharmaceutical manufacturer in Massachusetts is looking for a Clean Room Analyst to join their team. The role involves environmental monitoring and cleanroom qualifications in compliance with safety standards. Candidates should have at least an associate's degree in Microbiology or equivalent experience in a clean room environment. Excellent communication and interpersonal skills are essential. This full-time position requires on-site work in Marlborough and Agawam, with travel to client sites throughout New England.

Qualifications

• Requires 12 months working in a clean room environment.
• Sterile gowning experience preferred.
• Maintains a valid driver's license.

Responsibilities

• Perform environmental monitoring and cleanroom qualifications.
• Travel to regional client sites for testing and equipment expertise.
• Prepare and complete documentation per GDP.

Skills

Ability to read and interpret standard operating procedures

Mathematical skills for data analysis

Interpersonal skills

Excellent communication skills

Education

Associate’s degree in Microbiology or related field

High School Diploma with clean room experience

Job description

Overview

Join to apply for the TALENT PIPELINE - Clean Room Analyst - Microbiological Environmental Monitoring role at Cambrex. This talent pipeline is for future opportunities. If you are interested in joining our team but don\'t see a current role that fits your background, please submit your resume. If we have future opportunities that match your skillset, we will contact you. The position will be on-site at Cambrex locations in Massachusetts (Agawam and Marlborough).

Responsibilities

• As a Clean Room Services Analyst you will perform environmental monitoring and cleanroom qualifications within controlled environments.
• You will travel to regional client sites to provide your expertise with equipment, procedures, policies and regulations to ensure that their cleanrooms meet the requirements for safe manufacturing of medical devices, pharmaceuticals and other patient products.
• Expert use of scientific equipment while following policies and procedures
• Measure total air particulate, temperature, humidity and differential pressure
• Collect viable air and surface samples
• Collect purified water samples for testing
• Incubate media plates and enumerate any microbial growth
• Submit growth for microbial identification per procedure and client instruction
• Maintain and prepare equipment in a GMP environment
• Prepare and complete documentation (paper and electronic) per GDP
• Transport equipment and media to client sites within the New England region in company provided vehicles
• Familiarization with client cleanroom layouts, sampling plans and contamination control programs
• Sterile gowning and staging equipment and media into client cleanrooms for testing
• Other duties as assigned
• You will work with team members and under the direction of Cleanroom Services management to improve performance and client satisfaction
• Experienced Analysts will also
  • Perform compressed gas testing
  • Perform HEPA filter testing
  • Write risk assessments, sampling plans, investigations, protocols, reports, SOPs and other technical documents
  • Design and build electronic workflows
  • Peer review data
  • Assist with training
  • Cross-train to support other business functions, which may include: Validations, Metrology, Microbiology, Quality Assurance, Sales Support and Leadership

Qualifications/Skills

• Ability to read, analyze, interpret, and follow standard operating procedures, technical procedures, professional journals and governmental regulations to provide advantage to Cambrex opportunities.
• Mathematical skills including the ability to analyze scientific and test data, and a basic understanding of statistical analysis.
• Ability to effectively present information to internal and external audiences.
• Ability to write reports and business correspondences
• Actively participate in team and company meetings.
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with customers, partners and colleagues at all levels in an organization.
• Excellent communication skills: verbal, written and active listening.

Education, Experience & Licensing Requirements

Entry Level Qualifications

• Associate’s degree in Microbiology or related field with a minimum of 12 months of working in a clean room environment-OR- High School Diploma or equivalent will be considered with a minimum of 24 months of working in a clean room environment
• Sterile gowning experience preferred
• Maintains a valid driver’s license and has a good driving record.

Expert Level Qualifications

• Bachelor’s degree or higher in Microbiology or related field
• Minimum of 12 months of sterile gowning experience
• Minimum of 12 months of environmental monitoring sampling and testing experience
• CETA or NEBB training / certification preferred

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Travel

This role frequently performs work at client sites, so travel to and from client sites is part of the typical workday. Company vans are provided for travel to client sites, most of which are in southern New England. Approximately 10% of assignments are multi-day requiring overnight accommodation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk, hear, and read. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment And Protective Equipment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Human Resources

Industries

• Pharmaceutical Manufacturing